PreeclampsiaPLORGNCT06893978
Placental Organoids Development: Application in the Study of the Human Reproduction Pathophysiology.
An observational study of Preeclampsia and Pregnancy Loss, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Placental organoids represent an in vitro 3D reconstruction model of the human placenta and of its complex cellular organization to evaluate the pharmacological effect in terms of placentation, gene expression, protein synthesis and placental secretomics. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preeclampsia, Pregnancy Loss, Preterm Birth
- What is being tested?
- Placenta organoids treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 20 May 2025to Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
Study population: Women with normal pregnancy (n=5) or complicated by: * miscarriage (n=5); * preeclampsia (n=5); * preterm delivery (n=5); afferent to the U.O.C. of Obstetrics of the Agostino Policlinico Universitario Agostino Gemelli IRCCS of Rome.
Who may be able to join
- Women with uncomplicated normal term pregnancy undergoing elective cesarean section for previous uterine surgery or breech presentation of the fetus;
- Patients with retained abortion and history of recurrent abortion sine causa at the end of the work-up of investigations performed according to ESHRE guidelines, undergoing revision of the uterine cavity;
- Patients diagnosed with preeclampsia, defined in accordance with the definitions of ISSHP, undergoing cesarean section;
- Patients with preterm onset, before 37 weeks gestational age, of spontaneous labor, undergoing cesarean section in labor for low weight or abnormal fetal presentation.
Who cannot join
- Age <18 years;
- Chronic infection with HIV or HCV;
- Ongoing malignant neoplasms;
- Multiple pregnancies;
- Inability to provide informed informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Ostetricia e Patologia Ostetrica
Rome, Lazio, 00168
Chiara Tersigni, +390630157546, chiara.tersigni@policlinicogemelli.it
Chiara Tersigni, MD
About this study
Placental organoids represent an in vitro 3D reconstruction model of the human placenta and of its complex cellular organization to evaluate the pharmacological effect in terms of placentation, gene expression, protein synthesis and placental secretomics.
Read the detailed description
Placental organoids represent an in vitro 3D reconstruction model of the human placenta and of its complex cellular organization. Placental organoid model can be used in the study of placental pathophysiology. In in particular, it provides a personalized model for sartorial in vitro evaluation of personalized therapeutic efficacy of different pharmacological therapies. In particular, with placental organoid it is possible to evaluate the pharmacological effect in terms of placentation, gene expression, protein synthesis and placental secretomics.
- Conditions
- Preeclampsia, Pregnancy Loss, Preterm Birth, Healthy
- Being tested
- Placenta organoids treatment
- Medical subject headings
- Pre-Eclampsia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placenta organoids treatmentDrug
Placenta organoids in vitro treatment with heparin, aspirin, IVIG, filgrastim and metformin
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of placental 3D organoid model
Morphological characteristics of placental 3D organoids successfully developed from placentas obtained from full-term physiological pregnancies and pathological conditions (abortion, preeclampsia, preterm delivery).
Assessment Parameters: Organoid formation efficiency (%)
Measured: From the date of caesarean section until the development of placental organoids, assessed up to 36 months.
Characterization of placental 3D organoid model
Assessment of cell viability (live/dead staining)
Measured: From the date of caesarean section until the development of placental organoids, assessed up to 36 months.
Viability of Placental Organoids
Measurement of cell proliferation rate in normal and pathological placental organoids before and after anticoagulant, anti-inflammatory, and immunomodulatory treatments (heparin, aspirin, metformin, IVIg, filgrastim).
Assessment Parameters: Cell viability (live/dead staining)
Measured: From date of caesarean section until the development of placental organoids, until 36 months
Secondary outcomes (5)
Gene Expression in Placental Organoids
Quantification of tissue-specific gene expression in normal and pathological placental organoids before and after treatments.
Assessment Parameters: Differential expression of target genes (qPCR)
Measured: From date of caesarean section until the development of placental organoids, until 36 months
Secretome Analysis of Placental Organoids
Analysis of extracellular vesicles and soluble factors secreted by placental organoids before and after treatments.
Assessment Parameters: Quantification of cytokines by ELISA assay
Measured: From date of caesarean section until the development of placental organoids, until 36 months
Proliferative Capacity of Placental Organoids
Assessment of percentage of proliferating cells
Measured: From date of caesarean section until the development of placental organoids, until 36 months
Growth capacity of placental organoids
Assessment of organoid growth rate (diameter increase over time).
Measured: From date of caesarean section until the development of placental organoids, until 36 months
Protein expression in placental organoids
Assessment of differential expression of proteins by Western blot, immunohistochemistry.
Measured: From date of caesarean section until the development of placental organoids, until 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start20 May 2025 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chiara Tersigni, MD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06893978
- Sponsor's protocol ID
- 7203
- Acronym
- PLORG
- Status last verified
- Nov 2024
- First submitted
- 20 Nov 2024
- Last updated
- 20 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placental Organoids Development: Application in the Study of the Human Reproduction Pathophysiology.
- ClinicalTrials.gov ID
- NCT06893978
- Acronym / sponsor ID
- PLORG / 7203
- Conditions
- Preeclampsia, Pregnancy Loss, Preterm Birth, Healthy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 20 May 2025 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 25 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Placental organoids represent an in vitro 3D reconstruction model of the human placenta and of its complex cellular organization to evaluate the pharmacological effect in terms of placentation, gene expression, protein synthesis and placental secretomics.
Detailed description
Placental organoids represent an in vitro 3D reconstruction model of the human placenta and of its complex cellular organization. Placental organoid model can be used in the study of placental pathophysiology. In in particular, it provides a personalized model for sartorial in vitro evaluation of personalized therapeutic efficacy of different pharmacological therapies. In particular, with placental organoid it is possible to evaluate the pharmacological effect in terms of placentation, gene expression, protein synthesis and placental secretomics.
Study design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Women with normal pregnancy (n=5) or complicated by: * miscarriage (n=5); * preeclampsia (n=5); * preterm delivery (n=5); afferent to the U.O.C. of Obstetrics of the Agostino Policlinico Universitario Agostino Gemelli IRCCS of Rome.
Key inclusion criteria (4 listed)
- Women with uncomplicated normal term pregnancy undergoing elective cesarean section for previous uterine surgery or breech presentation of the fetus;
- Patients with retained abortion and history of recurrent abortion sine causa at the end of the work-up of investigations performed according to ESHRE guidelines, undergoing revision of the uterine cavity;
- Patients diagnosed with preeclampsia, defined in accordance with the definitions of ISSHP, undergoing cesarean section;
- Patients with preterm onset, before 37 weeks gestational age, of spontaneous labor, undergoing cesarean section in labor for low weight or abnormal fetal presentation.
Key exclusion criteria (5 listed)
- Age <18 years;
- Chronic infection with HIV or HCV;
- Ongoing malignant neoplasms;
- Multiple pregnancies;
- Inability to provide informed informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placenta organoids treatmentPlacenta organoids in vitro treatment with heparin, aspirin, IVIG, filgrastim and metformin | Drug | – |
Primary outcome
Development of placental 3D organoid model
Time frame: From the date of caesarean section until the development of placental organoids, assessed up to 36 months.
Morphological characteristics of placental 3D organoids successfully developed from placentas obtained from full-term physiological pregnancies and pathological conditions (abortion, preeclampsia, preterm delivery). Assessment Parameters: Organoid formation efficiency (%)
Characterization of placental 3D organoid model
Time frame: From the date of caesarean section until the development of placental organoids, assessed up to 36 months.
Assessment of cell viability (live/dead staining)
Viability of Placental Organoids
Time frame: From date of caesarean section until the development of placental organoids, until 36 months
Measurement of cell proliferation rate in normal and pathological placental organoids before and after anticoagulant, anti-inflammatory, and immunomodulatory treatments (heparin, aspirin, metformin, IVIg, filgrastim). Assessment Parameters: Cell viability (live/dead staining)
5 secondary outcomes
Gene Expression in Placental Organoids
Time frame: From date of caesarean section until the development of placental organoids, until 36 months
Secretome Analysis of Placental Organoids
Time frame: From date of caesarean section until the development of placental organoids, until 36 months
Proliferative Capacity of Placental Organoids
Time frame: From date of caesarean section until the development of placental organoids, until 36 months
Growth capacity of placental organoids
Time frame: From date of caesarean section until the development of placental organoids, until 36 months
Protein expression in placental organoids
Time frame: From date of caesarean section until the development of placental organoids, until 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chiara Tersigni, MD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia and Pregnancy Loss, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chiara Tersigni (+390630157546, chiara.tersigni@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of placental 3D organoid model (time frame: From the date of caesarean section until the development of placental organoids, assessed up to 36 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.